Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
|ClinicalTrials.gov Identifier: NCT00458250|
Recruitment Status : Completed
First Posted : April 10, 2007
Last Update Posted : November 18, 2008
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelated donor.
Some researchers have been performed transplantation from semi-matched (haploidentical) related donors with relatively good results.
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results.
Chinese populations have more homogenous genetic background than Iranians. In this project, we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Leukemia, Lymphoblastic, Acute||Procedure: Haploidentical hematopoietic stem cell transplantation Drug: Busulfan Drug: Cyclophosphamide Drug: CAMPATH-1H Drug: Cyclosporin A Drug: Methotrexate||Phase 1|
Haploidentical hematopoietic stem cell transplantation is a very important therapeutic intervention for treatment of some genetic disorders and hematological malignancies.
In the majority of cases, there is no matched related or unrelated donor. Haploidentical hematopoietic stem cell transplantation is a promising alternative for critical cases.
To avoid severe graft versus host disease (GVHD), two types of T cell depletion (TCD) had been used: total TCD and partial TCD.
Total TCD has disadvantages such as increased rate of rejection and relapse, and increased rate of infections due to delayed immune reconstitution.
Partial TCD has been done by in vivo and/or in vitro methods. In haploidentical transplantation, donor partial TCD (ex vivo TCD) without recipient TCD increases the rate of rejection and can not prevent severe GVHD successfully.
In vivo TCD by partial depletion of donor and recipient T cells has been done in haploidentical transplantation with good results (to some extent inferior to full matched transplantations) by using CAMPATH, ATG, etc.
Most of these studies have been performed in Chinese and Japanese populations that have more homogenous genetic background than other populations.
In order to study the feasibility of this kind of transplantation in Iranian patients, we defined a project to perform haploidentical hematopoietic stem cell transplantation by using in vivo CAMPATH-1H.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H|
|Study Start Date :||September 2006|
|Study Completion Date :||February 2008|
- Engraftment one month after transplantation [ Time Frame: Up to 30 days from transplantation ]
- six months survival [ Time Frame: Up to 180 days after transplantation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458250
|Iran, Islamic Republic of|
|Hematology-Oncology & BMT Research Center|
|Tehran, Iran, Islamic Republic of, 14114|
|Study Director:||Mohammadreza Ostadali, MD, Ph.D.||Hematology-Oncology & BMT Research Center|
|Principal Investigator:||Ardeshir Ghavamzadeh, MD||Hematology-Oncology & BMT Research Center|
|Principal Investigator:||Kamran Alimoghaddam, MD||Hematology-Oncology & BMT Research Center|